The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.
Breast cancer survival rates have greatly improved with advances in both screening and treatment. The standard of care for both early stage and selected locally advanced breast cancers is breast conserving therapy (BCT), consisting of a partial mastectomy followed by radiation treatment. Traditionally, a salvage mastectomy was the standard treatment for women who initially underwent BCT and experienced an ipsilateral breast tumor recurrence (IBTR). Many participants have become increasingly motivated to avoid mastectomy, and there has been rising interest in repeat BCS (Breast Conserving Surgery) with focal radiation for certain participants motivated to keep their breast. The current standard of care for breast re-irradiation after an in-breast tumor recurrence is partial breast irradiation consisting of a dose of 45 Gy delivered BID for 30 fractions. While this regimen demonstrated excellent local control and low AEs, the regimen itself is difficult for participants. Receiving RT twice daily at smaller doses per fraction (1.5 Gy) for 30 treatments can be burdensome, especially for those without reliable transportation or difficulty getting time away from work. Given the excellent local control rates and low rate of AEs, in this study, we hypothesize that daily hypofractionated EBRT(External Beam Radiation Therapy) for re-irradiation after repeat BCS would be at least as well tolerated with good local control and provide a more convenient option for participants than the current standard of care established by RTOG 1014. Some participants will present with high-risk features (e.g. age \<50, high grade, ER negative tumors, close margins) making dose escalation an attractive option to improve local control. Options for dose escalation include sequential and concurrent administration of a boost.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Weeks 1, 2 and 3 * Weeks 1, 2 and 3 will include 5 days of treatment. * One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes.
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGTreatment-related adverse events as graded by CTCAE criteria
Rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year from the completion of re-irradiation as graded by CTCAE criteria.
Time frame: 1 year from the completion of re-irradiation
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.
Time frame: 3 years
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate is estimated using the cumulative incidence function.
Time frame: 5 years
In-breast tumor recurrence rate
The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.
Time frame: 10 years
Rate of freedom from mastectomy
The freedom from mastectomy rate will be estimated using the cumulative incidence function.
Time frame: 3 years
Rate of freedom from mastectomy
The freedom from mastectomy rate will be estimated using the cumulative incidence function.
Time frame: 5 years
Rate of freedom from mastectomy
The freedom from mastectomy rate will be estimated using the cumulative incidence function.
Time frame: 10 years
Treatment-related adverse events
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Masking
NONE
Enrollment
55
All treatment-related adverse events for the defined time periods
Time frame: 1 year from completion of re-irradiation
Treatment-related adverse events
All treatment-related adverse events for the defined time periods
Time frame: Overall for 3 years from completion of re-irradiation
Evaluation of Cosmesis
Determined by an established Global Cosmesis Score grading from 1 through 4, with 1 being excellent and 4 being rated as poor
Time frame: 1 year
Evaluation of Cosmesis
Determined by an established Global Cosmesis Score grading from 1 through 4, with 1 being excellent and 4 being rated as poor
Time frame: 3 years
Overall survival rate
Overall survival will be estimated using Kaplan-Meier Method
Time frame: 3 years
Overall survival rate
Overall survival will be estimated using Kaplan-Meier Method
Time frame: 5 years
Overall survival rate
Overall survival will be estimated using Kaplan-Meier Method
Time frame: 10 years
Mastectomy-free survival rate
Mastectomy-free survival will be estimated using Kaplan-Meier Method
Time frame: 3 years
Mastectomy-free survival rate
Mastectomy-free survival will be estimated using Kaplan-Meier Method
Time frame: 5 years
Mastectomy-free survival rate
Mastectomy-free survival will be estimated using Kaplan-Meier Method
Time frame: 10 years